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Diss Factsheets
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EC number: 948-910-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 May 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 25 June 2018
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Essential oil of Tanacetum annuum
- IUPAC Name:
- Essential oil of Tanacetum annuum
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Baileys Turkeys Ltd., Cheshire, UK, (Spring chickens (Gallus Gallus e.g. Ross 308 Broiler))
- Number of animals: Multiple
- Characteristics of donor animals (e.g. age, sex, weight): approximately 3 kg and approximately 56 days old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Following slaughter, the intact chicken heads were placed into individual plastic compartments within a plastic box in order to minimize any damage to the eyes. The base of each compartment was lined with a paper towel moistened with isotonic saline. The heads were transported to the test facility at ambient temperature.
- Time interval prior to initiating testing: same day
- indication of any existing defects or lesions in ocular tissue samples: The integrity of the cornea was measured with a drop of 2% (w/v) sodium fluorescein to the surface of the cornea and then rinsed with isotonic saline after a few seconds. The treated eyes were examined with the use of the Haag-Streit BQ 900 (Switzerland) microscope, to examine for damage to the cornea
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.03 mL to the cornea
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- 10 seconds
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES: Eyes that had a high baseline fluorescein staining (>0.5) or corneal opacity score (>0.5) after the enucleation process were rejected. Eyelids were carefully excised and the integrity of the cornea was measured with a drop of 2% (w/v) sodium fluorescein to the surface of the cornea and then rinsed with isotonic saline after a few seconds. The treated eyes were examined for damage of cornea with the use of the Haag-Streit BQ 900 (Switzerland) microscope, An acceptable eye for the ICE test was one where the fluorescein retention and corneal opacity scores are or smaller then 0.5.
Enucleated eyes were transferred to an appropriate clamp keeping the cornea vertical. They were then transferred to chambers within the superfusion apparatus ensuring the corneas received sufficient isotonic saline from the saline drip and examined again for damage. The temperature of the chambers was at 32 ±1.5 °C.
EQUILIBRATION AND BASELINE RECORDINGS
After the approval process the eyes were incubated for approximately 45 minutes for equilibrium purposes. Time zero measurements for corneal thickness and opacity were taken to serve as a baseline. The baseline for the fluorescein measurements were taken at dissection.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: Sodium chloride 0.9% w/v
POSITIVE CONTROL USED: Benzalkonium chloride 5 v/v
APPLICATION DOSE AND EXPOSURE TIME: 0.3 mL was applied for 10 seconds
REMOVAL OF TEST SUBSTANCE
- Volume and washing procedure after exposure period: After 10 seconds of exposure, the surface of the cornea was rinsed with 20 mL isotonic saline.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: calculated with the most densely opacified areas for scoring
- Damage to epithelium based on fluorescein retention: calculated at the 30 minute time interval only
- Swelling: measured with optical pachymeter on a slit-lamp microscope; slit-width setting: Percentage corneal swelling was assessed from corneal thickness measurements.
- Macroscopic morphological damage to the surface: evaluated with Haag-Streit BQ 900 (Switzerland) microscope
DECISION CRITERIA:
Once each endpoint had been established, ICE classes were determined based on a predetermined range. The overall in vitro irritancy classification of the test item was determined by using all the
results applied it to ICE classification criteria. A test was considered acceptable if the concurrent negative or vehicle/solvent items and the concurrent positive controls were identified as GHS Non-Classified and GHS Category 1, respectively.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Run / experiment:
- 0, 30, 75, 120, 240 minutes
- Value:
- 0.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean
- Run / experiment:
- 30 minutes
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Run / experiment:
- 30 minutes
- Value:
- 4.46
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Run / experiment:
- 75 minutes
- Value:
- 9.41
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Run / experiment:
- 120 minutes
- Value:
- 8.42
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Run / experiment:
- 180 minutes
- Value:
- 7.43
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean
- Run / experiment:
- 240 minutes
- Value:
- 10.89
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes, valid positive and negative controls.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (mean corneal opacity 0, mean Fluorescein retention 0, Mean corneal swelling up to 3.70%; 3x ICE class I)
- Acceptance criteria met for positive control: yes (mean corneal opacity up to 4.0, mean Fluorescein retention 2.7, Mean corneal swelling up to 39.60%; 3x ICE class IV)
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria (Annex I of 1272/2008/EC)
- Conclusions:
- Under the conditions of this test, Blue Tansy oil does not need to be classified for eye irritation, according to the criteria laid down in Annex I of 1272/2008/EC (CLP).
- Executive summary:
In an isolated chicken eye test, performed according to the 438 OECD Guideline under GLP conditions, Blue Tansy oil was tested to evaluate the eye hazard potential of the substance. 0.3 mL of the test item was applied to the cornea of each of 3 chicken enucleated eyes and after 10 seconds the corneas were rinsed with isotonic saline. After the exposure, toxic effects were measured by qualitative assessment of opacity (0.3, ICE class I), fluorescein retention (0.5 ICE class I), and corneal swelling (10.89% ICE class II). Valid positive (overall ICE class IV) and negative (overall ICE class I) controls were included. According to the overall in vitro irritancy criteria, the ICE classes combined for teat item lead to result ‘no Category’. Therefore under the conditions of this test, the test item does not need to be classified for eye irritation, according to the criteria laid down in Annex I of 1272/2008/EC (CLP).
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